<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220213054013N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-09</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of IVIg therapy on Covid 19 patients.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of IVIg therapy on blood (WBC، lymphocyte count), renal (Cr, urea) and liver parameters (AST, ALT) in COVID-19 patients before and after IVIg therapy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>196</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronavirus (Covid-19).</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": In this study, patients with severe type or severity of COVID-19 disease, in addition to other treatments and according to the doctor, had a dose of IVIg treatment, will be included in the study. To eliminate confounders, the control group is used for adaptation and the patients in the control group will be selected almost similar to the study group in terms of sex and age. The results of hematological, hepatic and renal parameters before IVIg injection will be compared with the results of the fourth day after IVIG and will be analyzed. Intervention 2: "Control group": In this study, the control group of patients with severe or severity of COVID-19 disease who receive other therapies of the intervention group except IVIg will be included in the study. This work is used to eliminate confounding factors and for fitting, and patients in the control group will be selected almost similar to the study group in terms of sex and age. The results of hematological, hepatic and renal parameters before IVIg injection will be compared with the results of the fourth day after IVIG and will be analyzed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of tests and clinical findings of patients will be presented in the article after the publication of the article.

When:
6 months later

To whom:
Fields of the Department of Medical Sciences and scientists in this field

Conditions:
To use or not to use this type of treatment according to the results

Where to obtain:
Use the extracted article or request it from Behrooz Ghezelbash via email.
behroozghezelbash@med.mui.ac.ir

How to obtain:
By prior arrangement and sending email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behrooz Ghezelbash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, پزشکPhysician School</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 9231</telephone>
        <email>behroozghezelbash@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behrooz Ghezelbash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, School of Medicine</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 9231</telephone>
        <email>behroozghezelbash@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having laboratory and clinical results of COVID-19
Positive PCR test for COVID-19
Do not have other allergic diseases and cancer</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking any immunosuppressive drugs during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": In this study, patients with severe type or severity of COVID-19 disease, in addition to other treatments and according to the doctor, had a dose of IVIg treatment, will be included in the study. To eliminate confounders, the control group is used for adaptation and the patients in the control group will be selected almost similar to the study group in terms of sex and age. The results of hematological, hepatic and renal parameters before IVIg injection will be compared with the results of the fourth day after IVIG and will be analyzed.</i_keyword>
      <i_keyword>"Control group": In this study, the control group of patients with severe or severity of COVID-19 disease who receive other therapies of the intervention group except IVIg will be included in the study. This work is used to eliminate confounding factors and for fitting, and patients in the control group will be selected almost similar to the study group in terms of sex and age. The results of hematological, hepatic and renal parameters before IVIg injection will be compared with the results of the fourth day after IVIG and will be analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum IL-6 levels. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of the level  of IL-6 before and 4 days after the intervention in comparison with the control group with laboratory equipment.</prim_outcome>
      <prim_outcome>Serum BUN level. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of the level  of BUN before and 4 days after the intervention in comparison with the control group with laboratory.</prim_outcome>
      <prim_outcome>Serum Cr level. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of the level of Cr before and 4 days after the intervention in comparison with the control group with laboratory.</prim_outcome>
      <prim_outcome>Fever. Timepoint: The day before the intervention until the fourth after the intervention. Method of measurement: Measurement of the patient's body temperature before and after treatment up to the fourth day after the intervention and comparison of the two groups.</prim_outcome>
      <prim_outcome>Oxygen saturation rate. Timepoint: The day before the intervention until the fourth day after the intervention. Method of measurement: Measurement of oxygen saturation in arterial blood of the patient before and after treatment up to the fourth day after the intervention and comparison of the two groups.</prim_outcome>
      <prim_outcome>Lymphocyte count. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Counting of patients' blood lymphocytes (number per microliter) before and 4 days after the intervention in comparison with the control group with laboratory equipment.</prim_outcome>
      <prim_outcome>Platelet count. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Counting of patients' blood platelets (number per microliter) before and 4 days after the intervention compared with the control group using cell counter.</prim_outcome>
      <prim_outcome>Serum sodium level (Na). Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of sodium in the patient's blood in terms of milliequivalents per liter, before and after treatment until the fourth day after the intervention and comparison of the two groups using a flame photometer.</prim_outcome>
      <prim_outcome>Potassium (K). Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of potassium in the patient's blood in milliequivalents per liter, before and after treatment until the fourth day after the intervention and comparison of the two groups using a flame photometer.</prim_outcome>
      <prim_outcome>AST. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Assessment of AST enzyme level before intervention and 4 days after comparison with control group using autoanalyzer.</prim_outcome>
      <prim_outcome>ALT. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Assessment of ALT enzyme level before intervention and 4 days after comparison with control group using autoanalyzer.</prim_outcome>
      <prim_outcome>LDH. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Assessment of LDH enzyme level before intervention and 4 days after comparison with control group using autoanalyzer.</prim_outcome>
      <prim_outcome>D-dimer. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of D-dimer before and 4 days in comparison with the control group using laboratory equipment.</prim_outcome>
      <prim_outcome>ESR. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of ESR before and 4 days compared to the control group using Westergreen method.</prim_outcome>
      <prim_outcome>CRP. Timepoint: The day before the intervention and the fourth day after the intervention. Method of measurement: Measurement of CRP in patients' serum before and 4 days after the intervention in comparison with the control group using an autoanalyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-02</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
